Updated Overall Survival Analysis From the Phase II PHAROS Study of Encorafenib Plus Binimetinib in Patients With BRAF V600E-Mutant Metastatic Non–Small Cell Lung Cancer

Author(s): Melissa L. Johnson, MD1; Egbert F. Smit, MD, PhD2; Enriqueta Felip, MD, PhD3; Suresh S. Ramalingam, MD4; Myung-Ju Ahn, MD, PhD5; Anne Tsao, MD6; Bruce E. Johnson, MD7; Michael Offin, MD8; Maen Hussein, MD9; Ibiayi Dagogo-Jack, MD10; Jonathan W. Goldman, MD11; Jeffrey M. Clarke, MD12; Marcelo V. Negrao, MD6; Rachel E. Sanborn, MD13; Daniel Morgensztern, MD14; Tiziana Usari, BSc15; Keith Wilner, PhD16; Linh Alejandro, PharmD16; Nada Rifi, MD17; Xiaosong Zhang, MD, PhD18; Gregory J. Riely, MD, PhD8;
Source: DOI: 10.1200/JCO-25-02023
Original Article
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This update demonstrated that encorafenib plus binimetinib was associated with the longest median overall survival (mOS) reported to date among targeted therapies in patients with treatment-naïve BRAF V600E–mutant metastatic NSCLC (mNSCLC). Median OS was 47.6 months in treatment-naïve patients. By the way check the authors there 😊.

ABSTRACT

AbstractThe phase II PHAROS study previously showed that encorafenib plus binimetinib has antitumor activity in patients with BRAF V600E-mutant metastatic non–small cell lung cancer (mNSCLC). In PHAROS, 98 patients (59 treatment-naïve; 39 previously treated) received encorafenib 450 mg once daily and binimetinib 45 mg twice daily. We report updated results from data cutoff of March 14, 2025. The median duration of treatment with both encorafenib and binimetinib was 16.3 months in treatment-naïve and 5.5 months in previously treated patients. After median follow-up for overall survival (OS) of 52.3 months in treatment-naïve patients, mOS was 47.6 months (95% CI, 31.3 to not estimable); 4-year OS probability was 49% (95% CI, 35 to 62). After median follow-up for OS of 48.2 months in previously treated patients, mOS was 22.7 months (95% CI, 14.1 to 32.6); 4-year OS probability was 31% (95% CI, 16 to 47). In treatment-naïve and previously treated groups, 58% and 26% received ≥1 subsequent systemic anticancer treatment, respectively. Safety profile remained consistent with that in previous analyses. Although comparisons across trials should be done cautiously, to our knowledge, encorafenib plus binimetinib was associated with the longest mOS reported to date with targeted treatment in patients with treatment-naïve BRAF V600E-mutant mNSCLC.

Author Affiliations

1Sarah Cannon Research Institute, Nashville, TN; 2Department of Pulmonary Diseases, Leiden University Medical Center, Leiden, the Netherlands; 3Oncology Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology, Barcelona, Spain; 4Winship Cancer Institute of Emory University, Atlanta, GA; 5Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; 6Department of Thoracic/Head & Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; 7Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA; 8Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY; 9Florida Cancer Specialists, Sarah Cannon Research Institute, Leesburg, FL; 10Cancer Center and Department of Medicine, Massachusetts General Hospital, Boston, MA; 11Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA; 12Department of Medicine, Duke Cancer Institute, Durham, NC; 13Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR; 14Department of Medicine, Washington University School of Medicine, St Louis, MO; 15Pfizer, Milan, Italy; 16Pfizer, La Jolla, CA; 17Pfizer, Paris, France; 18Pfizer, South San Francisco, CA

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